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RECRUITINGPHASE3

Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy

Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy: a Multicenter Randomized Controlled Phase III Clinical Trial

NCT04829708•Shandong Cancer Hospital and Institute

View on ClinicalTrials.gov

Summary

This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. PCI is performed in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. MRI surveillance alone (delaying radiation until the actual brain metastasis) may be not inferior to PCI.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histological or cytological confirmation of LS-SCLC before first-line chemoradiotherapy (according to the staging system of the Veterans' Affairs Lung Study Group (VALSG), Appendix 2)；
•2. Remission is achieved after first-line chemoradiotherapy (CR or PR determined by RECIST v1.1)；
•3. Brain MRI examination should be performed to exclude metastatic lesions of brain parenchyma and meninges within four weeks before enrollment；
•4. The ECOG PS score was 0\~2；
•5. The interval between the end of the last treatment cycle and the randomized grouping should be no more than 8 weeks；
•6. Estimated survival time ≥ 12 weeks；
•7. Patients must agree to participate in the study, comply with the research plan and follow-up process. Written informed consent must obtained.
•8. Male or female aged≥18 and≤75 years old;
•9. For fertile women and man: Subjects are required to agree to maintain abstinence (no heterosexual intercourse) or use contraception with an annual failure rate of less than 1% during the study treatment period and within at least 6 months after the end of the study treatment period.
•10. Hematological indexes: absolute neutrophil count≥1.5×109/ L, platelet count≥75×109 /L, haemoglobin≥9.0g/dL, serum albumin≥3g/dL；
+4 more criteria

Exclusion Criteria

•1. Patients with extensive SCLC (Appendix 2)；
•2. The subjects are confirmed to have brain or meningeal metastasis before they are randomly divided into groups；
•3. During the 5 years before the start of the study, patients with malignant tumors other than SCLC, diseases with negligible risk of metastasis or death (such as expected 5-year OS \> 90%) and malignant tumors expected to be cured (such as fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated by curable surgery, ductal carcinoma in situ treated by curable surgery)；
•4. Previous head and neck radiation fields overlapped with PCI field；
•5. MRI examination contraindicated
•6. There is evidence that significantly uncontrolled concomitant disease may affect the compliance of the study program, including severe liver disease (such as liver cirrhosis), uncontrollable major seizures or superior vena cava syndrome；
•7. Major cardiovascular diseases, myocardial infarction or cerebrovascular events within 3 months before randomization, unstable arrhythmias, or unstable angina pectoris；
•--Patients with known coronary artery disease, congestive heart failure that do not meet the above criteria, or left ventricular ejection fraction ((LVEF)) \< 50% must receive a stable treatment plan and optimize it according to the advice of the attending physician, and consult a cardiologist if necessary。
•8. Stroke (including hemorrhagic and ischemic) or transient ischemic attack occurred within 6 months before enrollment；
•9. There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before entering the group, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis or vasculitis；
+11 more criteria

Locations (2)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, China

Key Dates

Start Date

April 26, 2021

Primary Completion Date

April 15, 2026

Completion Date

April 15, 2028

Last Updated

April 29, 2021

Enrollment

534

ESTIMATED participants

Conditions

Limited Stage Small Cell Lung Cancer

Interventions

MRI Surveillance

OTHER

Prophylactic Cranial Irradiation

RADIATION

Contacts

Jinming Yu, PhD

CONTACT

+8613806406293 sdyujinming@126.com

Xiangjiao Meng, PhD

CONTACT

+8613793150996 mengxiangjiao@126.com

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

NCT06117774

Limited Stage Small Cell Lung CancerSmall Cell Lung Cancer

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RECRUITINGPHASE2

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

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Limited Stage Small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy

Inclusion Criteria

Exclusion Criteria

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

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